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Completed Phase 3 Interventional Results available

Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

ClinicalTrials.gov ID: NCT03009396

Public ClinicalTrials.gov record NCT03009396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 2:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study

Study identification

NCT ID
NCT03009396
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
RedHill Biopharma Limited
Industry
Enrollment
54 participants

Conditions and interventions

Conditions

Interventions

  • RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 76 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 17, 2017
Primary completion
Nov 12, 2018
Completion
Aug 18, 2019
Last update posted
Feb 23, 2021

2017 – 2019

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Digestive Care Associates, Inc., 1000 Laurel Street San Carlos California 94070
Gastrointestinal Specialists of Georgia PC 711 Canton Rd. #300 Marietta Georgia 30060
Cotton-O'Neil Clinical Research Center, 720 SW Lane St. Topeka Kansas 66606
Chevy Chase Clinical Research, 5550 Friendship Blvd. Chevy Chase Maryland 20815
Commonwealth Clinical Studies, 189 Quincy St. Brockton Massachusetts 02302-2926
ClinSearch 6035 Shallowford Road Suite 109 Chattanooga Tennessee 37421

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03009396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 23, 2021 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03009396 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →